Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene

NCT ID: NCT02913235

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the present investigation is to record and compare bacterial compositions in supragingival plaque samples and saliva samples in subjects discontinuing regular oral hygiene for 10 days. The hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to discontinuation of oral hygiene.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

35 orally healthy individuals will be enrolled in this study, in which they will discontinue regular oral hygiene procedures for a period of 10 days. Clinical registrations and collection of microbiological samples (supragingival and saliva) will be performed at baseline and 4, 7 and 10 days after discontinuation of regular oral hygiene, and will be repeated 14 days after regular oral hygiene has been resumed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mouth Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral hygiene discontinuation group

The intervention of the present study is discontinuation of regular oral hygiene procedures for a period of 10 days. Discontinuation of oral hygiene will allow undisturbed biofilm formation (supragingival dental plaque) along the gingival margin of the teeth. After 10 days all individuals will resume regular oral hygiene. Clinical registrations and collection of microbiological samples (supragingival and saliva) will be performed at baseline and 4, 7 and 10 days after discontinuation of regular oral hygiene, and will be repeated 14 days after regular oral hygiene has been resumed.

Group Type EXPERIMENTAL

Oral hygiene discontinuation group

Intervention Type PROCEDURE

Discontinuation of regular oral hygiene for 10 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral hygiene discontinuation group

Discontinuation of regular oral hygiene for 10 days

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Oral and systemically healthy individuals

Exclusion Criteria

* Periodontitis
* Dental caries
* Systemic diseases or medications with known associations to oral health
* Antibiotics within the latest 6 month
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Forsyth Institute

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Belstrøm, DDS, PhD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Belstrøm, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

References

Explore related publications, articles, or registry entries linked to this study.

Belstrom D, Sembler-Moller ML, Grande MA, Kirkby N, Cotton SL, Paster BJ, Twetman S, Holmstrup P. Impact of Oral Hygiene Discontinuation on Supragingival and Salivary Microbiomes. JDR Clin Trans Res. 2018 Jan;3(1):57-64. doi: 10.1177/2380084417723625. Epub 2017 Jul 31.

Reference Type DERIVED
PMID: 29662960 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCPH_OI_002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.